Hyderabad-based Granules’ US arm clears US FDA audit

The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.

Hyderabad: Hyderabad-based Granules India announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company located in Chantilly, Virginia, USA had undergone a pre-approval inspection (PAI) audit by the US Food and Drug Administration (FDA) from 21st June to 25th June 2021.

The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.

“The observations were responded to within the stipulated time, and we are happy to inform that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021. This is the fifth US FDA audit for this facility,” said Priyanka Chigurupati, ED, GPI.

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